GlaucomaNCT01774227
the Pops-titration Versus the Slow-coagulation Cyclophotocoagulation in Treatment of Refractory Glaucoma
A study testing The pops-titration group and The slow-coagulation group in people with Glaucoma and Intraocular Pressure, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Transcleral cyclophotocoagulation (TSCPC) has long been used as refractory glaucoma management and is very easy to learn and easy to perform. Recent advances in laser technology; the role of TSCPC is being expanded because it has benefits of noninvasive glaucoma procedure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glaucoma, Intraocular Pressure
- What is being tested?
- The pops-titration group and The slow-coagulation group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteThailand
- Study dates
- May 2013to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Refractory glaucoma (Neovascular glaucoma) with
- Eyes with no visual potential and very high intraocular pressure (on maximal medical treatment) in which the intraocular pressure will probably cause corneal complications
- Eyes with no visual potential and very high intraocular pressure (on maximal medical treatment) in which the intraocular pressure cause eye pain and need pain relief
- Eyes with minimal useful vision and intraocular pressure over the target intraocular pressure
- Eyes in which trabeculectomy with mitomycin-C and/or drainage implants have a high probability of failure
- Eyes in which trabeculectomy with mitomycin-C and/or drainage implants have previously failed
- Patient refuses to undergo more aggressive intraocular surgery
- Patients whose general medical condition precludes invasive surgery
Who cannot join
- The visual acuity in the fellow eye is no light perception
- Have previously been treated by the transcleral cyclophotocoagulation
- Allergy to anesthetic medication
- Can not measure the intraocular pressure by the applanation method
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Ophthalmology Department, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: A Randomized Trial of the Pops-titration Versus the Slow-coagulation Energy Delivery Technique on the Outcome of Diode Laser Transcleral Cyclophotocoagulation in Treatment of Neovascular Glaucoma With Dark Iris
- Transcleral cyclophotocoagulation (TSCPC) has long been used as refractory glaucoma management and is very easy to learn and easy to perform.
- Recent advances in laser technology; the role of TSCPC is being expanded because it has benefits of noninvasive glaucoma procedure.
- The titration (pops), the fixed high-energy, and the fixed-low energy (slow-coagulation) are three energy delivery techniques.
- The present study would report on the outcome (efficacy and safety) of the slow-coagulation versus the titration method in treatment of refractory glaucoma with dark iris.
- The results would provide reliable evidences to supplement clinical judgment when making a decision in favor of each treatment method for glaucoma patients.
Read the detailed description
- Several protocols afford delivery of the "optimum" dose of laser energy per session necessary to achieve a long-term effective ocular hypotensive response balancing risks related to a high energy treatment and risks related to retreatment due to suboptimum dose delivery.
- There are two main approaches to delivering laser energy, the pops-titration method and the fixed energy method that are the fixed-high and low-energy (the Gaasterland's slow-coagulation technique).
- Of particular interest is which laser energy delivery method (slow-coagulation versus pops-titration) affords the optimal dose of photocoagulation necessary to achieve an effective long-term intraocular pressure (IOP) reduction while minimizing the risk of adverse events related to overtreatment and retreatments especially in refractory glaucomatous eyes with dark iris color.
- Conditions
- Glaucoma, Intraocular Pressure
- Being tested
- The pops-titration group, The slow-coagulation group
- Keywords
- Refractory glaucoma, Transcleral cyclophotocoagulation (TSCPC), Dark iris, Pops-titration, Slow-coagulation, Neovascular glaucoma
- Medical subject headings
- Glaucoma, Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The pops-titration groupProcedure or surgery
The energy delivery is started at a low level and is increased in intervals till an audible pop is heard, following which the power is reduced downward until the pops are no longer audible, then the treatment is completed at these parameters
The slow-coagulation groupProcedure or surgery
The Gaasterland's slow-coagulation energy delivery technique using the lower power for the longer duration.
| Study group | Role | What they receive |
|---|---|---|
| The pops-titration group | Experimental | The titration method uses power that is titrated according to the audible "pop". Receives: Procedure: The pops-titration group |
| The slow-coagulation group | Experimental | The slow-coagulation group utilize the low-energy using the Gaasterland's slow-coagulation technique Receives: Procedure: The slow-coagulation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Success rate defined as the proportion of eyes achieving an intraocular pressure between 6 and 21mmHg with or without topical antiglaucoma medication at the final follow up visit.
Measured: 60 months
Secondary outcomes (3)
Response rate
Response rate defined as the proportion of eyes achieving an intraocular pressure between < 22 mmHg or > 30% drop in an intraocular pressure with or without topical antiglaucoma medication at the final follow up visit.
Measured: 60 months
Cyclodiode efficacy index
Cyclodiode efficacy index defined as the ratio of response rate to the mean number of the treatment session.
Measured: 60 months
Failure rate
Failure rate defined as the proportion of eyes developed hypotony or phthisis bulbi or need to repeat treatment for more than 2 laser sessions.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weerawat Kiddee, Prince of Songkla University
- Investigators
- Weerawat Kiddee, MD, Study director, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774227
- Sponsor's protocol ID
- EC 56-094-02-1-2
- Status last verified
- Mar 2020
- First submitted
- 17 Jan 2013
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kiddee W, Kittigoonpaisan K, Leelaprasasne S, Tanjana A. Randomized clinical trial for pop titrated versus the slow coagulation cyclophotocoagulation in treating dark irises neovascular glaucoma. Sci Rep. 2025 Aug 18;15(1):30238. doi: 10.1038/s41598-025-16306-9.
PubMed 40826269
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of the Pops-titration Versus the Slow-coagulation Energy Delivery Technique on the Outcome of Diode Laser Transcleral Cyclophotocoagulation in Treatment of Neovascular Glaucoma With Dark Iris
- ClinicalTrials.gov ID
- NCT01774227
- Acronym / sponsor ID
- EC 56-094-02-1-2
- Conditions
- Glaucoma, Intraocular Pressure
- Keywords
- Refractory glaucoma, Transcleral cyclophotocoagulation (TSCPC), Dark iris, Pops-titration, Slow-coagulation, Neovascular glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Transcleral cyclophotocoagulation (TSCPC) has long been used as refractory glaucoma management and is very easy to learn and easy to perform.
- Recent advances in laser technology; the role of TSCPC is being expanded because it has benefits of noninvasive glaucoma procedure.
- The titration (pops), the fixed high-energy, and the fixed-low energy (slow-coagulation) are three energy delivery techniques.
- The present study would report on the outcome (efficacy and safety) of the slow-coagulation versus the titration method in treatment of refractory glaucoma with dark iris.
- The results would provide reliable evidences to supplement clinical judgment when making a decision in favor of each treatment method for glaucoma patients.
Detailed description
- Several protocols afford delivery of the "optimum" dose of laser energy per session necessary to achieve a long-term effective ocular hypotensive response balancing risks related to a high energy treatment and risks related to retreatment due to suboptimum dose delivery.
- There are two main approaches to delivering laser energy, the pops-titration method and the fixed energy method that are the fixed-high and low-energy (the Gaasterland's slow-coagulation technique).
- Of particular interest is which laser energy delivery method (slow-coagulation versus pops-titration) affords the optimal dose of photocoagulation necessary to achieve an effective long-term intraocular pressure (IOP) reduction while minimizing the risk of adverse events related to overtreatment and retreatments especially in refractory glaucomatous eyes with dark iris color.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The pops-titration group | Experimental | Procedure: The pops-titration groupThe titration method uses power that is titrated according to the audible "pop". |
| The slow-coagulation group | Experimental | Procedure: The slow-coagulation groupThe slow-coagulation group utilize the low-energy using the Gaasterland's slow-coagulation technique |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Refractory glaucoma (Neovascular glaucoma) with
- Eyes with no visual potential and very high intraocular pressure (on maximal medical treatment) in which the intraocular pressure will probably cause corneal complications
- Eyes with no visual potential and very high intraocular pressure (on maximal medical treatment) in which the intraocular pressure cause eye pain and need pain relief
- Eyes with minimal useful vision and intraocular pressure over the target intraocular pressure
- Eyes in which trabeculectomy with mitomycin-C and/or drainage implants have a high probability of failure
Key exclusion criteria (4 listed)
- The visual acuity in the fellow eye is no light perception
- Have previously been treated by the transcleral cyclophotocoagulation
- Allergy to anesthetic medication
- Can not measure the intraocular pressure by the applanation method
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The pops-titration groupThe energy delivery is started at a low level and is increased in intervals till an audible pop is heard, following which the power is reduced downward until the pops are no longer audible, then the treatment is completed at these parameters | Procedure or surgery | The pops-titration group |
| The slow-coagulation groupThe Gaasterland's slow-coagulation energy delivery technique using the lower power for the longer duration. | Procedure or surgery | The slow-coagulation group |
Primary outcome
Success rate
Time frame: 60 months
Success rate defined as the proportion of eyes achieving an intraocular pressure between 6 and 21mmHg with or without topical antiglaucoma medication at the final follow up visit.
3 secondary outcomes
Response rate
Time frame: 60 months
Cyclodiode efficacy index
Time frame: 60 months
Failure rate
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Derived from this study: PubMed 40826269Kiddee W, Kittigoonpaisan K, Leelaprasasne S, Tanjana A. Randomized clinical trial for pop titrated versus the slow coagulation cyclophotocoagulation in treating dark irises neovascular glaucoma. Sci Rep. 2025 Aug 18;15(1):30238. doi: 10.1038/s41598-025-16306-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weerawat Kiddee, MD study director
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The pops-titration group and The slow-coagulation group in people with Glaucoma and Intraocular Pressure, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01774227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.